BERKELEY HEIGHTS, N.J. — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated, commercial stage biotechnology company, today announced the publication of a paper, “Steady-State Pharmacokinetic Properties of TNX-102 SL, a Sublingual Tablet Formulation of Cyclobenzaprine Hydrochloride (HCl), With Daily Dosing in Healthy Volunteers: A Randomized, Open-Label...
treatment News
Ionis completed a Phase 2 clinical study evaluating cimdelirsen (IONIS-GHR-LRx) as an addon therapy in patients with uncontrolled acromegaly despite stable therapy with long-acting somatostatin receptor ligands (SRL). Based on the results of this Phase 2 study and a preliminary analysis of the ongoing open-label study, proof of mechanism was...
BOSTON, Mass. — Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics, today announced that it met the key secondary endpoint of PFS and showed additional compelling results in the randomized COMPANION-002 study, which evaluated tovecimig plus paclitaxel versus paclitaxel alone in patients with unresectable...
SAN DIEGO, Calif. — Tr1X, a clinical-stage biopharmaceutical company developing first-in-class allogeneic engineered type 1 regulatory (Tr1 Treg) and CAR-Tr1 Treg cell therapies with the potential to cure autoimmune and inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND)...
Bottom Line: The MEK inhibitor trametinib (Mekinist) was an effective treatment for pediatric patients with relapsed or refractory juvenile myelomonocytic leukemia (JMML) enrolled in a phase II clinical trial, with seven of 10 patients alive after a median of two years. Journal in Which the Study was Published:...
BOSTON, Mass. — TransCode Therapeutics, Inc. (NASDAQ: RNAZ), a clinical stage company pioneering immuno-oncology and RNA therapeutics for the treatment of high risk and advanced cancer, today announced the publication of preclinical research supporting the application of its lead candidate, TTX-MC138, for the treatment of glioblastoma multiforme (GBM). The article was published...
SAN DIEGO, Calif. — Transposon Therapeutics, a biotechnology company developing a platform of novel, orally administered therapies for the treatment of neurodegenerative and aging-related diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to TPN-101 for progressive supranuclear palsy (PSP). “Fast...
NANJING, China and GAITHERSBURG, Md. — TransThera Sciences Inc. (“TransThera”) announced the publication of clinical results from a US-based Phase 2 trial evaluating tinengotinib in patients with Cholangiocarcinoma (CCA) on The Lancet Gastroenterology and Hepatology (Impact Factor: 38.6). Cholangiocarcinoma (CCA) is an aggressive malignancy of the bile ducts, frequently driven by FGFR2 fusions-genomic...
SAN DIEGO, CA — Travere Therapeutics Inc. (Nasdaq: TVTX) today announced the completion of a successful pre-NDA meeting with the U.S. Food and Drug Administration (FDA) for FILSPARI® (sparsentan) in IgA nephropathy (IgAN). The Company will submit a supplemental New Drug Application (sNDA) in the first quarter of 2024 for...
SAN DIEGO, Calif. — Travere Therapeutics, Inc., (Nasdaq: TVTX) announced that today the U.S. Food and Drug Administration (FDA) has extended the review timeline of its supplemental New Drug Application (sNDA) for FILSPARI® (sparsentan) in focal segmental glomerulosclerosis (FSGS). The new Prescription Drug User Fee Act (PDUFA) target action date is...